The LightSpeed VCT System is intended for head and whole body X-ray Computed Tomography applications.

Code Information

All serial numbers

Recalling Firm/Manufacturer

GE Healthcare3000 N Grandview BlvdWaukesha, Wisconsin 53188-1615

Manufacturer Reasonfor Recall

When the manual cradle release feature on the table is used to move a patient out of the gantry, a discrepancy of up to 6mm between the numerical display on the gantry and the actual position of the table could be introduced.

FDA DeterminedCause 2

DESIGN: Software Design

Action

A Product Safety Advisory Notice, dated December 8, 2006, was issued to all customers informing them of the safety issue and production correction. Customers are advised to operate the CT cradle as intended with the system''s electronic controls. If a critical need arises to release the cradle during a radiation therapy simulation scan, they are advised to independently verify patient position prior to marking the patient for therapy to avoid the potential inaccuracy. A software update will be installed to correct this problem by a GE representative.